Current Drug Shortages: BICNU (Carmustine) Injection, 100 mg (NDC 00015-3012-60)
Tuesday, 10 May 2011 12:10
1-877-946-7747200 mg/mL, 30 mL (NDC 00409-3308-03)Increase in demandHospira has 100 mg/mL; 30 mL (NDC 0409-3307-03) and 200 mg/mL; 30 mL (NDC 0409-3308-03) vials on back order with an estimated release date of May 2011, with recovery targeted for July 2011.Roxane Laboratories
1-614-276-4000200 mg/mL, 10 mL (NDC 00054-3028-02), 200 mg/mL, 30 mL (NDC 00054-3026-02)Increase in demandRoxane Labs has available acetylcysteine inhalation solution 100 mg/mL 10 mL (NDC 00054-3027-02) and 30 mL (NDC 00054-3025-02) vials. The 200 mg/mL 10 mL and 30 mL vials are on back order and the company estimates a release date of late-May 2011.American Regent/Luitpold
631-924-4000100 mg/mL, 4 mL (NDC 00517-7504-25), 100 mg/mL, 10 mL (NDC 00517-7510-03), 200 mg/mL, 4 mL (NDC 00517-7604-25), 200 mg/mL, 10 mL (NDC 00517-7610-03), 200 mg/mL, 30 mL (NDC 00517-7630-03)Manufacturing delaysAmerican Regent has all acetylcysteine inhalation solution presentations on back order and the company cannot estimate a release date. Amikacin Injection (updated 5/10/2011)CompanyReasonRelated InformationTeva Pharmaceuticals
1-800-545-8800Manufacturing delaysTeva has amikacin 250 mg/mL 2 mL (NDC 00703-9032-03) and 4 mL (NDC 00703-9040-03) vials on allocation. If a pharmacy cannot obtain product from their wholesaler, please have the wholesaler contact Teva directly to place an emergency order.Bedford Customer Service
1-800-562-4797Manufacturing delaysBedford anticipates release of the 500mg and 1g presentations in late May. The 100mg presentation has been discontinued. Amino Acid Injection (updated 2/17/2011)Company/ProductsReasonRelated InformationHospira Customer Service
1-877-946-7747Commodity shortage
Hospira Information (PDF - 15KB)Baxter Customer Service:
1-888-229-0001Increase in demandBaxter has the following bulk pharmacy Amino Acid Injections for compounding on allocation and is working to increase production to meet US market demand.
Clinisol, Baxter
Clinisol 15%, 500 mL (NDC 00338-0502-03)
Clinisol 15%, 2000 mL (NDC 00338-0502-06)
Prosol, Baxter Prosol 20%, 2000 mL (NDC 00338-0499-06)
Travasol, Baxter
Travasol 10%, 500 mL (NDC 00338-0644-03)
Travasol 10%, 1000 mL (NDC 00338-0644-04) Travasol 10%, 2000 mL (NDC 00338-0644-06)
1-800-227-2862Increase in demand
All FreAmine 10% (S9010-SS & S9011-SS), TrophAmine 10% (S9341-SS) , and TrophAmine 6%( S9361-SS) products are off allocation and currently available to all customers via direct or indirect distribution, as inventory is very healthy to support new customers.
Feel free to contact your local B. Braun sales representative or place orders via Customer Service at 800-227-2862.
Ammonium chloride injection, 5 mEq/mL, 20 mL vial (NDC 00409-6043-01) (2/1/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
Hospira Customer Service | Supply interruption | Hospira has ammonium chloride 5 mEq/mL 20 mL vials on back order and the company estimates a release date of 2nd quarter, 2011. |
Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10% (9/18/2008)
| Company/Products | Reason | Related Information |
|---|---|---|
Ucyclyd Pharma, Inc. 1-888-829-2593, or 1-800-900-6389 with a representative available 24 hours, seven days a week. | See information in Related Information section. | Limited supplies continue to be available. Please see attached Dear Healthcare Professional Letter (PDF - 66KB) for important safety information. |
Amphetamine Mixed Salts, ER Capsules (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Shire Customer Service: 1-800-828-2088 Adderall XR capsules | API supply issues and uneven product distribution patterns. | Expect increased product availability in May 2011. Shire Customer Service Number: 1-800-828-2088 Shire Pharmacy Locator Number: 1-800-828-2088 select “Option 5” for assistance in locating a pharmacy in your area with product availability. |
| Teva Customer Service (888)838-2872 5 mg - 100 count (NDC 00555-0790-02); 10 mg - 100 count (NDC 00555-0787-02); 15 mg - 100 count (NDC 00555-0791-02); 20 mg - 100 count (NDC 00555-0788-02); 25 mg - 100 count (NDC 00555-0792-02); 30 mg - 100 count (NDC 00555-0789-02) | API supply issues | 20 mg and 30 mg market availability: approx 4/14/11. All other strengths market availability: approx 4/29/11. |
| Global Customer Service: (215)558-4300 10 mg ,100 count (NDC 00115-1329-01); 15 mg, 100 count (NDC 00115-1330-01); 20 mg, 100 count (NDC 00115-1331-01); 25 mg, 100 count (NDC 00115-1332-01); 30 mg, 100 count (NDC 00115-1333-01) | API supply issues | All product strengths other than 25 mg are currently available on an allocated basis. |
Aquasol A, 50,000 units/mL, 2 mL ampule (NDC 61703-418-07) (12/7/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. 1-877-946-7747 | Change in manufacturing sites. | Hospira anticipates releasing product sometime in 2011. |
Arginine 10% injection (R-Gene 10) (11/30/2010)
Avalide (irbesartan and hydrochlorothiazide)Tablets (3/25/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bristol-Myers Squibb 1-800-321-1335 | Manufacturing delays | Please see the following link for updated information: Bristol-Myers Squib |
BICNU (Carmustine) Injection, 100 mg (NDC 00015-3012-60)
(5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bristol-Myers Squibb 1-800-321-1335 | Manufacturing delays at contract manufacturer | Bristol-Myers Squibb has BICNU injection on back order and the company estimates a release date of late-May 2011. |
Bleomycin Injection (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| APP 1-888-386-1300 15 unit vial (NDC 63323-0136-10), 30 unit vial (NDC 63323-0137-20) | Increased demand | APP is currently back-ordered on all presentations of Bleomycin for Injection at this time. APP is anticipating batch releases to resume in the first quarter of 2011. |
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing delays | 15 unit vials (NDC 00703-3154-01) and 30 unit vials (NDC 00703-3155-01) are now available and the company is reviewing orders prior to shipping. |
| Bedford 1-800-562-4797 15 unit vial (NDC 55390-0005-01), 30 unit vial (NDC 55390-0006-01) | Product discontinued | Bedford currently has all presentations discontinued. |
| Hospira 1-877-946-7747 15 unit vial (NDC 61703-0332-18) 30 unit vial (NDC 61703-0323-22) | Manufacturing delays | Backordered until 1Q 2011. |
Calcium Chloride Injection (9/9/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. 1-877-946-7747 | Unanticipated Increased Demand | Hospira is continuing to release calcium scholride 100 mg/mL Injection 10 mL Ansyr syringes (NDC 00409-1631-10) and 10 mL LifeShield syringes (NDC 00409-4928-34) as they become available. |
| American Regent, Inc. 1-800-645-1706 | American Regent, Inc. currently has Calcium Chloride Injection, USP 100 mg/mL in a 10 mL vial available. Due to increases in demand, American Regent, Inc. may not be able to fill all orders. Contact your wholesaler regarding product availability. | |
| Amphastar Pharmaceuticals, Inc./IMS 1--800-423-4136 | Amphastar (IMS) in cooperation with FDA will re-introduce its emergency syringes including Dextrose 50%, Epinephrine 0.1mg/mL, Calcium Chloride 100mg/mL, Sodium Bicarbonate 8.4%, Atropine Sulfate 0.1mg/mL, Lidocaine 2%, and Morphine 1mg/mL. Calcium Chloride 100mg/ml syringes (NDC 0548-3304-00/product code 3304) were released by Amphastar/IMS on 9/7/10 and are now available. |
Calcium Gluconate (4/1/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| APP 1-888-386-1300 100 mg/mL vials, 10 mL vials (NDC 63323-0311-10)50 mL vials (NDC 63323-0311-50) 100 mL vials (NDC 63323-0311-61) | Increased Demand | APP has all calcium gluconate products on intermittent back-order, due to increased demand, and the company has regular releases and distributes inventory directly to the wholesale channel. Please check with your wholesaler for all available inventory. APP has the 10mL vials (63323-311-10) and 100mL vials (63323-311-61) on back-order with estimated releases mid-March, 2011. APP has the 50mL vials (63323-311-50) also on backorder with estimated release early-April, 2011. The 200mL vials have been discontinued. |
| Luitpold 631-924-4000 50 mL (NDC 0051703950-25), and 100 ml NDC (00517-3900-25) vials | Increase in demand | American Regent has calcium gluconate 100 mg/mL 50 mL and 100 mL vials on back order. The 10 mL vials have been discontinued. |
Cisplatin injection 1 mg/mL solution (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| APP 1-888-386-1300 | Increased Demand | APP is continuing to allocate as releases occur: 50 mL vial (NDC 63323-0103-51), 100 mL vial (NDC 63323-0103-65) and 200 mL vial (NDC 63323-0103-64). |
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing delays | Teva continues to release cisplatin injection 1 mg/mL solution. 50 mL vial (NDC 00703-5747-11) and 100 mL vial (NDC 00703-5748-11) as it becomes available. |
| Bedford 1-800-562-4797 | Product discontinued | Bedford currently has all presentations discontinued. |
Cleviprex 0.5 mg/mL 50 mL vial (NDC 65293-0002-50) 100 mL vial (NDC 65293-0002-00) (3/22/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| The Medicines Company | See Related Information Section | Please visit: Recall -- Firm Press Release regarding recall of certain lots that may contain particulate matter. No information at this time regarding when the product will be available. |
Cytarabine injection (powder for reconstitution) (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Customer Service 1-800-562-4797 100 mg vial (NDC 55390-0131-10) | Manufacturing delays | Release of Bedford’s 1g presentation is anticipated in early May; the 100 mg presentation in the next 3-months; the 500 mg presentation in the next 6-months. The 2g presentation has been discontinued. |
| APP 1-888-386-1300 100 mg/mL, 20 mL vial (NDC 63323-0120-20) | Manufacturing delays | Limited supplies available - please see attached Dear Healthcare Professional Letter (PDF - 43KB) for important information. APP has been able to increase production to help address the shortage and estimates additional supplies to be released by end of April. |
| Hospira Inc. 1-877-946-7747 20 mg/mL; 50 mL PBP (NDC 61703-303-46), 20 mg/mL; 25 mL (NDC 61703-304-36), 20 mg/mL; 5 mL (NDC 61703-305-38), 100 mg/mL 20 mL (NDC 61703-319-22) | API shortage/manufacturing delay | Hospira will begin releasing additional lots of 100mg/ml 20ml vials on April 11, 2011. |
Daunorubicin hydrochloride solution for injection (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Teva Pharmaceuticals 1-800-545-8800 5 mg/mL, 4 mL single-dose vial (NDC 00703-5233-13) | Manufacturing issues | Teva has daunorubicin solution for injection on back order and estimates a release date of August, 2011. |
| Bedford Customer Service 1-800-562-4797 5 mg/mL, 4 mL single-dose vial (NDC 55390-0108-10), 10 mL single-dose vial (NDC 55390-0108-01) Cerubidine lyophilized powder for injection, 20 mg single-dose vial, package of 10 (NDC 55390-0281-10) | Manufacturing delays | Bedford will release 20 mg lyophilized powder for injection in early May. Bedford will release daunorubicin solution for injection, 20 mg and 50 mg, in the next 3-months. |
Desmopressin injection (2/1/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Ferring 1 888 Ferring (1-888-337-7464) 4 mcg/mL 1ml vials (NDC 55566-5030-01) and 4mcg/mL 10ml (NDC 55566-5040-01) | n/a | Ferring is continuing to release product as soon as it becomes available. |
| Hospira Inc. 1-877-946-7747 (4 mcg/mL, 1 mL amp (NDC 00409-2265-01)) | Increased demand/manufacturing delays | Hospira has available desmopressin 4 mcg/mL 1 mL vials (NDC 00409-2265-01). |
| Sanofi-Aventis 1-800-981-2491 (DDAVP 4 mcg/mL 1 mL (NDC 00075-2451-01) and 10 mL (NDC 00075-2451-53)) | Unanticipated increased demand | Sanofi is continuing to release product as soon as it becomes available. |
| Teva Pharmaceuticals 1-800-545-8800 (4 mcg/mL, 1 mL vial, 10 count (NDC 00703-5051-03) 10 mL multi-dose vial (NDC 00703-5054-01)). | Manufacturing delays | Teva has available desmopressin 4 mcg/mL 1 mL (NDC 00703-5051-03) and 10 mL (NDC 00703-5054-01) vials and is reviewing orders prior to release. |
Dexamethasone Injection (3/25/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| American Regent Inc. (1-800-645-1706) | Manufacturing issues | American Regent has recalled a number of their dexamethasone 4 mg/mL presentations due to the presence of particulate matter. The firm has placed their product on hold with no estimated release date. |
| APP (1-888-386-1300) | Increased demand | All 4mg/mL Dexamethasone codes are currently on allocation due to increase demand: 4mg/mL-1mL (NDC 63323-165-01), 4mg/mL-5mL (NDC 63323-165-05), 4mg/mL-30mL (NDC 63323-165-30). The 10mg/mL-1mL ( NDC 63323-506-01) and 10mg/mL-10mL (NDC 63323-516-10) presentations are currently available. APP is continuing to release the product as it becomes available. |
Digoxin Injection (updated 5/5/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service: 1-888-229-0001 USP 250 mcg/mL, 2 mL ampuls (NDC 0641-1410-35) | Increase in product demand. | Baxter is currently experiencing a back order situation on the 2 mL ampuls (NDC 0641-1410-35). Baxter has accelerated production and will have product available by the end of April. |
| Sandoz Customer Service: 1-609-627-8500 USP 250 mcg/mL, 2 mL (NDC 0781-3059-95) | Manufacturing delays | Sandoz anticipates supply in 3Q 2011. |
| GlaxoSmithKline Customer Service: 888-825-5249 Lanoxin Injection, USP 250 mcg/mL, 2 mL (50s - NDC 00173-0260-35) | Manufacturing delays | GSK has discontinued the manufacturing Lanoxin Injection, USP 250 mcg/mL, 2 mL (50s - NDC 00173-0260-35) 250 mcg/mL, 2 mL (10s - NDC 00173-0260-10) is currently on back-order and should be available January 2012. |
Diltiazem Injection 5 mg/mL (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service 1-888-229-0001 5 mL vial (NDC 10019-510-01) 10 mL vial (NDC 10019-510-02) 25 mL vial (NDC 10019-510-04) | Baxter has accelerated production due to an increase in product demand. | Baxter is experiencing a back order situation on all codes and estimates the following product availability: 5 mL vial (NDC 10019-510-01) Additional product releases expected later this month and at the end of May. 10 mL vial (NDC 10019-510-02) - Product will be available end of May 25 mL vial (NDC 10019-510-04) - Product releases expected by mid April and end of May. Product will be made available as it is released. |
| Hospira Customer Service (1-877-946-7747) 5 mg/mL, 5 mL vials (NDC 00409-1171-01); 5 mg/mL, 10 mL vials (NDC 00409-1171-02) 100 mg/mL, ADD-Vantage vials (NDC 00409-4350-03) | Manufacturing delays | Hospira will have diltiazem 5 mg/mL 5 mL (NDC 00409-1171-01) and 5mg/ml; 10 mL vials (NDC 00409-1171-02) available late-April. The 100mg/ml ADD-Vantage vials (NDC 00409-4350-03) are on back order with an estimated release date of mid-April, 2011. Emergency supplies of the ADD-Vantage vials are available for direct orders. |
| Bedford Customer Service 1-800-562-4797 5 mg/mL 5 mL vials (NDC 55390-0565-05), 5 mg/mL 10 mL vials (NDC 55390-0565-10) 5 mg/mL 25 mL vials (NDC 55390-0565-30), 5 mg/mL 5 mL Novaplus vials (NDC 55390-0566-05) 5 mg/mL 10 mL Novaplus vials (NDC 55390-0566-10), 5 mg/mL 25 mL Novaplus vials (NDC 55390-0566-30) | Manufacturing delays | Bedford anticipates release of all presentations in the next 3 months. |
Doxorubicin (adriamycin) lyophilized powder (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford 10 mg vials (NDC 55390-0231-01) 20 mg vials (NDC 55390-0232-10) 50 mg vial (NDC 55390-0233-01) | Manufacturing delays | Bedford anticipates release of all presentations in the next 6-months. |
Doxorubicin Solution for Injection (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| APP 1-888-386-1300 APP Product Availability Information | Increased demand | APP is releasing the 2mg/ml 100 ml vials (NDC 63323-0101-61), the 2mg/ml 25 ml vials (NDC 63323-0883-30), and the 2mg/ml 5 ml vials (NDC 63323-0883-05) as it becomes available. |
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing delays | Teva is releasing all strengths on allocation: Doxorubicin solution for injection, 2 mg/mL 5 mL vial (NDC 00703-5043-03) 25 mL vial (NDC 00703-5046-01) 100 mL vial (NDC 00703-5040-01). |
| Bedford 1-800-562-4797 | Manufacturing delays | Bedford anticipates release of the 50mg presentation in the next 3months and release of the 10 mg, 25 mg, and 100 mg solutions in the next 6-months. |
Erythromycin lactobionate injection (12/22/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. 1-877-946-7747 | Manufacturing delays | Hospira anticipates releasing 500 mg Add-Vantage (NDC 0409-6476-44) and 500 mg vial NDC (0409-6482-01) in 1Q2011. |
Ethiodol (ETHIODIZED OIL) ampules (12/10/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Guerbet LLC Customer Service (1-877-729-6679) | Product has been discontinued by Nycomed US Inc. | Guerbet has acquired the Ethiodol NDA from Nycomed US Inc. effective May 7, 2010 and is working with FDA to resume manufacturing of Ethiodol in the near future to ensure continued availability for the US patients. During this interim period, Guerbet, in conjunction with the FDA, is initiating a temporary importation of LIPIODOL ULTRA-FLUIDE, ethyl esters of iodized fatty acids of poppy seed oil, to the United States market. See Dear Healthcare Professional Letter (PDF - 588KB) for additional information. |
Etoposide solution for injection (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford 1-800-562-4797 | Increased demand | Bedford anticipates release of 500 mg product in early May, 1g in the next 3-months, and 100 mg in the next 6-months. |
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing delays | Teva has Toposar 20 mg/mL solution for injection 5 mL vials (NDC 00703-5653-01) vials availalbe. The 25 mL and 50 mL vials are on back order. |
| APP 1-888-386-1300 | Manufacturing delays | APP is releasing all etoposide solution for injection 20 mg/mL presentations as they become available. |
| BMS Customer Service 1-800-426-7644 | Increased demand | BMS has available Etopophos 100 mg powder for injection (NDC 00015-3404-20). |
Fabrazyme (agalsidase beta) (3/25/2011)
Fentanyl Transdermal System (updated 5/2/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Ortho-McNeil Janssen Customer Service: 1-800-526-7736 Duragesic Transdermal System, 50 mcg/hr - 5 count (NDC 50458-0092-05); 75 mcg/hr - 5 count (NDC 50458-0093-05); 100 mcg/hr - 5 count (NDC 50458-0094-05); 12 mcg/hr - 5 count (NDC 50458-0090-05); 25 mcg/hr - 5 count (NDC 50458-0091-05) | N/A | All presentations are currently available. |
| Apotex Corp. Apotex Customer Service: 1-(877)-4-Apotex 50 mcg/hr - 5 count (NDC 60505-7002-2), single (NDC 60505-7002-0); 75 mcg/hr - 5 count (NDC 60505-7003-2) single (NDC 60505-7003-0); 100 mcg/hr - 5 count (NDC 60505-7004-2), single (NDC 60505-7004-0); 25 mcg/hr - 5 count (NDC 60505-7001-2), single (NDC 60505-7001-0) | N/A | All product available. |
| Sandoz Customer Service: 1-609-627-8500 50 mcg/hr - 5 count (NDC 00781-7112-55); 75 mcg/hr - 5 count (NDC 00781-7113-55); 100 mcg/hr - 5 count (NDC 00781-7114-55); 25 mcg/hr - 5 count (NDC 00781-7111-55) | Manufacturing issues | Timeframe for return currently unavailable. |
| Mylan Customer Service: 1-800-796-9526 50 mcg/hr - 5 count (NDC 00378-9122-98); 75 mcg/hr - 5 count (NDC 00378-9123-98); 100 mcg/hr - 5 count (NDC 00378-9124-98); 12 mcg/hr - 5 count (NDC 00378-9119-98); 25 mcg/hr - 5 count (NDC 00378-9121-98) | Not Applicable; Capable of Supplying 100 % of Market Demand | All product available for immediate shipment. |
| Watson Customer Service: 724-514-1800 or 800-272-5525 50 mcg/hr - 5 count (NDC 00591-3212-72), single (NDC 00591-3212-54); 75 mcg/hr - 5 count (NDC 00591-3213-72), single (NDC 00591-3213-54); 100 mcg/hr - 5 count (NDC 00591-3214-72), single (NDC 00591-3214-54); 25 mcg/hr - 5 count (NDC 00591-3198-72), single (NDC 00591-3198-54) Novaplus Fentanyl Transdermal System, 50 mcg/hr - 5 count (NDC 00591-3601-72), single (NDC 00591-3601-54); 75 mcg/hr - 5 count (NDC 00591-3602-72), single (NDC 00591-3602-54); 100 mcg/hr - 5 count (NDC 00591-3603-72), single (NDC 00591-3603-54); 25 mcg/hr - 5 count (NDC 00591-3600-72), single (NDC 00591-3600-54) | N/A | All product available. |
| Actavis Customer Service: 800-432-8534 or fax (973) 993-4300 or E-mail: This e-mail address is being protected from spambots. You need JavaScript enabled to view it | N/A | All product available. |
| Mallinckrodt Inc. (800) 325-8888 50 mcg/hr (NDC 0406-9050-76); 75 mcg/hr (NDC 0406-9075-76); 100 mcg/hr (NDC 0406-9000-76); 25 mcg/hr (NDC 0406-9025-76) | N/A | All product available. |
Foscarnet sodium 24 mg/mL injection (9/27/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira, Inc. | Manufacturing delays | Hospira is working to resolve the manufacturng delay concerning the 250 mL, package of 12 (NDC 00409-3863-02) and 500 mL, package of 12 (NDC 00409-3863-05) and additional information on availability will be forthcoming. Please see Dear Healthcare Professional Letter (PDF -1MB) for information about emergency supplies that are now available from Clinigen to help address the shortage. |
Fosphenytoin Sodium Injection (2/1/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Laboratories 1-800-562-4797 | Not currently marketed | Bedford will be off the market for an undefined period of time. |
| Hospira 1-877-946-7747 | Manufacturing delays | Supply Information for Hospira (PDF - 15KB) |
| Akorn Pharmaceuticals 1-800-932-5676 | Not currently marketed | Akorn will be off the market for an undefined period of time. |
| APP 1-888-386-1300 | Increase in demand | APP continues to release product as it becomes available. |
| West-Ward Pharmaceuticals Customer Service: 1-800-631-2174 | Increase in demand | West-Ward has available NDC# 0143-9788-25 fosphenytoin 150 mg/2ml and NDC# 0143-9782-10 fosphenytoin 750 mg/10 ml. |
| American Regent, Inc. 1-800-645-1706 | Newly launched product | American Regent has available fosphenytoin 75 mg/mL in 2 ml vials (NDC 00517-6902-25). |
Furosemide Injection 10mg/ml (12/27/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. 1-877-946-7747 | Manufacturing delays | Hospira is releasing the 10 mg/mL, 2 mL vial (NDC 0409-6102-02 ), 10 mg/mL, 4 mL vial (NDC 0409-6102-04) , 10 mg/mL, 10 mL bottle (NDC 0409-6102-10). Additional supplies of 10 mg/mL, 4 mL Ansyr syringe (NDC 0409-9631-04) , 10mg/ml 10 ml Ansyr Syringe (NDC 0409-1639-10) will be available in early 2011. |
| American Regent, Inc. 1-800-645-1706 | Increase in demand | American Regent, Inc., the distributor of Furosemide Injection, USP 10 mg/mL manufactured by Luitpold Pharmaceuticals, Inc., will continue to notify its wholesalers of the product release dates for all three presentations of Furosemide Injection, USP 10 mg/mL (2 mL vial, 4 mL in a 5 mL vial and 10 mL vial) so they can communicate product availability and appropriately allocate to the end use. |
| APP 1-888-386-1300 | Increase in demand | APP has available furosemide 10 mg/mL injection 2 mL (NDC 63323-0280-02) and 4 mL (NDC 63323-0280-04) vials. |
Haloperidol Decanoate Injection (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing delays | Teva has all presentations on back order. |
| Ortho-McNeil Janssen 1-800-526-7736 | See Related Information | Ortho-McNeil has Haldol Decanoate available in 50 mg/mL 1 mL ampoules in 3 count (NDC 00045-0253-03) presentations and 100 mg/mL 1 mL ampoules (NDC 00045-0254-14). |
| APP Pharmaceuticals 1-888-386-1300 | See Related Information | APP has haloperidol decanoate available in 50 mg/mL 5 mL vials (NDC 63323-0469-05). 100 mg/mL 5 mL vials (NDC 63323-0471-05) and 100 mg/mL 1mL vials (NDC 63323-0471-01) and 50 mg/mL 1 mL vials (NDC 63323-0469-01) are being released as they become available. |
| Bedford Laboratories Customer Service 1-800-562-4797 | Product discontinued | Bedford has all presentations of the Haloperidol Decanoate discontinued. |
Intravenous Fat Emulsion (1/19/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira (Liposyn III Emulsion) Customer Service: 1-877-946-7747 | Manufacturing issues | Hospira has the following Liposyn III emulsion (soybean oil) products on backorder. Hospira is working with FDA to address the issues that led to the shortage. 10% 250 mL (NDC 00409-9790-02) 10% 500 mL (NDC 00409-9790-03) 20% 250 mL (NDC 00409-9791-02) 20% 500 mL (NDC 00409-9791-03) 30% 500 mL (NDC 00409-6892-03) |
| Baxter (Intralipid Emulsion) Customer Service: (1-888-229-0001) | Baxter now has adequate supply available to meet demand. | Baxter has the following Intralipid emulsions available through normal distribution: 20% 100 mL (NDC 00338-0519-48) 20% 250 mL (NDC 00338-0519-02) 20% 500 mL (NDC 00338-0519-03) 20% 1000 mL (NDC 00338-0519-04) 30% 500 mL (NDC 00338-0520-03) |
Leucovorin Calcium Lyophilized Powder for Injection (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Laboratories Customer Service 1-800-562-4797 | Manufacturing delays | Bedford anticipates release of 200mg and 350mg lyophilized product in early May, 500mg liquid product in early May, and 100mg and 50mg lyophilized product in the next 3-months. |
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing delays | Teva has leucovorin calcium lyophilized powder 100 mg and 350 mg vials on back order and the company does not anticipate release until April 2011. |
| APP Pharmaceuticals 1-888-386-1300 | APP has recently launched their leucovorin injection in response to the ongoing shortage. | APP is currently back-ordered. Initial supplies are limited, however APP is continuing to produce and release leucovorin calcium lyophilized powder for injection (NDC# 63323-710-50 for the 200mg SDV and NDC# 63323-711-00 for the 500mg SDV). |
Levoleucovorin (Fusilev) 50 mg single use vials (3/7/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Spectrum Pharmaceuticals 1-877-387-4538 or 1-877-FUSILEV | Due to the shortage of both leucovorin and levoleucovorin products, the FDA has utilized regulatory enforcement discretion for Spectrum Pharmaceuticals, Inc. to temporarily import levoleucovorin 100 mg Powder for Injection manufactured by Pfizer Inc. Please see the Dear Healthcare Professional Letter (PDF - 159KB) for additional information. | Reminder: There is potential for dosing errors when interchanging leucovorin and levoleucovorin (Fusilev). The dose of levoleucovorin (Fusilev) is one-half the dose of racemic leucovorin injection (e.g., levoleucovorin [Fusilev] 7.5 mg = racemic leucovorin 15 mg). For more information visit: Spectrum Pharmaceuticals |
Levorphanol 2mg Tablets (12/3/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Roxane Laboratories 1-614-276-4000 | Manufacturing delays | Product anticipated to be available soon. |
Lorazepam Injection 2 mg/ml (updated 5/9/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service: 1-888-229-0001 2 mg/mL, 1 mL vial (NDC 10019-0102-01), 1 mL Novaplus vial (NDC 10019-0105-01), 10 mL vial (NDC 10019-0102-10) | Baxter has accelerated production due to an increase in product demand. | Baxter has lorazepam 2 mg/mL, 10 mL vials (NDC 10019-0102-10) currently available for distribution. The 2 mg/mL, 1 mL vial presentation (NDC 10019-0102-01) will be on back order until the end of April. |
| Bedford Laboratories Customer Service: 1-800-562-4797 2 mg/mL, 1 mL vial (NDC 55390-0168-10), 10 mL vial (NDC 55390-0170-10) | Not currrently marketed. | Bedford has all lorazepam injection presentations on long-term back order and the company cannot estimate a release date. |
| Hospira: 1-877-946-7747 2 mg/mL, 1 mL vial (NDC 00409-6778-02), 10 mL vial (NDC 00409-6780-02), 2mg/mL Carpuject Luer Lock Slim-Pak (NDC 0409-1985-30) 4mg/ml, 1mL vial (NDC 0409-6779-02) | Increased demand | All presentations anticipated to be released in mid to late April, 2011. Please note that 2mg/ml 1 mL iSecure prefilled syringes (NDC 00409-1985-05) and 4mg/ml 1mLCarpuject syringes (NDC 0409-1539-31) are temporarily unavailable. |
| Akorn: 847-279-6100 | N/A | Akorn has Lorazepam injection available. |
Methylphenidate HCl (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Sandoz Customer Service: 1-609-627-8500 5 mg (100s - NDC 00781-8840-01 & 00781-5748-01; 1000s - NDC 00781-8840-10), 10 mg (100s - NDC 00781-5749-01 & 00781-8841-01; 1000s - NDC 00781-1749-10), 20 mg (100s - NDC 00781-8842-01 & 00781-5753-01; 1000s - NDC 00781-1753-10) 20 mg (100s - NDC 00781-8843-01 & 00781-5754-01) | Capacity constraints and receiving API orders. | Expect sporadic backorders for the next couple of months. |
| Mallinckrodt Customer Service: (800) 325-8888 5 mg (100s - NDC 00406-1121-01; 1000s - NDC 00406-1121-10), 10 mg (100s - NDC 00406-1122-01; 1000s - NDC 00406-1122-10), 20 mg (100s - NDC 00406-1124-01; 1000s - NDC 00406-1124-10) Methylin ER, 10 mg (100s - NDC 00406-1423-01) and 20 mg (100s - NDC 00406-1451-01) | This shortage is due to Active Pharmaceutical Ingredient (API) constraints. | Mallinckrodt expects to have continued gradual improvement over the next two months, with full recovery by July 2011. |
| UCB Customer Service: 1-800-477-7877 5 mg (100s - NDC 53014-0531-07), 10 mg (100s - NDC 53014-0530-07), and 20 mg (100s - NDC 53014-0532-07) Metadate ER Tablets, 20 mg (100s - NDC 53014-0594-07) Metadate CD, 10 mg (100s - NDC 53014-0579-07), 20 mg (100s - NDC 53014-0580-07), 30 mg (100s - NDC 53014-0581-07), 40 mg (100s - NDC 53014-0582-07), 50 mg (100s - NDC 53014-0583-07), and 60 mg (100s - NDC 53014-0584-07) | Increased demand | UCB has all presentations of 5 mg IR available. All UCB presentations of 10 mg IR, 20 mg IR, and 20 mg ER, are out of stock. The out of stock tablets are expected to be on intermittent backorder until approximately May 20. |
| Watson Customer Service: (973) 355-8300 5 mg (100s - NDC 00591-5882-01), 10 mg (100s - NDC 00591-5883-01), and 20 mg (100s - NDC 00591-5884-01) | n/a | Continues to have product available. |
Metoclopramide injection (2/4/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service: (1-888-229-0001) 5 mg/mL, 2 mL vial, 25 count (NDC 10019-0450-02) | Increased Demand | Baxter is currently experiencing an increase in demand for metoclopramide injection 5 mg/mL, 2 mL vials (NDC 10019-0450-02). Lots are currently being manufactured and will be release for distribution as product becomes available. |
| Hospira Inc. 1-877-946-7747 5 mg/mL 2 mL vials (NDC 00409-3414-01) | Hospira discontinued metoclopramide ampules in February, 2010, and Carpuject syringes in May, 2009. | Hospira has available metoclopramide injection 5 mg/mL 2 mL vials (NDC 00409-3414-01). |
| Teva Pharmaceuticals 1-800-545-8800 5 mg/mL, 2 mL vial, 25 count (NDC 00703-4502-04) | Teva has made a business decision to discontinue this product. See the Dear Valued Customer Letter (PDF - 32KB) |
Mexiletine Capsules (150mg, 200mg, and 250mg) (9/24/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Teva Pharmaceuticals 1-800-545-8800 | Manufacturing Delays | Teva has mexiletine 150 mg capsules (NDC 00093-8793-01) and 250 mg capsules (NDC 00093-8741-01). There is not yet an availability date for the 200 mg capsules. |
Mustargen (mechlorethamine HCl) injection (9/30/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Lundbeck Inc. Customer service number: 1-888-514-5204 | See Related Information | Lundbeck is currently working closely with FDA to gain approval of the transfer of production of Mustargen to a new manufacturing site after the company’s previous contractor discontinued commercial manufacturing of the product. Lundbeck expects Mustargen to be available again during 2011. Updates will be provided as they become available. Please see the Dear Healthcare Professional Letter (PDF - 24KB) from Lundbeck for additional information. |
MVI injectable (Adult and pediatric) (4/5/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira 1-877-946-7747 | Manufacturing delays relative to all adult formulations; Hospira is working to restore adequate supply, however, no timing is available. | MVI Pediatric 5mL Single Dose Vial (NDC 61703-421-53): Product is in adequate supply. |
| Baxter (Infuvite adult and pediatric IV solution) Customer Service: 1-888-229-0001 | Manufacturing delays | Infuvite is now available for Baxter. |
Nalbuphine Injection (3/17/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira 1-877-946-7747 NDC and Product Description: 10 mg/mL; 1 mL Novaplus amp NDC 0409-1463-49 10 mg/mL; 10 mL vial NDC 0409-1464-01 20 mg/mL; 1 mL amp NDC 0409-1465-01 20 mg/mL; 1 mL Novaplus amp NDC 0409-1465-49 10 mg/mL; 10 mL vial NDC 0409-1467-01 | Manufacturing delays | Hospira has 10 mg/mL 1 mL ampules (NDC 00409-1463-01), and 20 mg/mL 1 mL ampules (NDC 00409-1465-01), 10 mL vials (NDC 00409-1467-01), The 10 mg/mL 10 mL vials are anticipated to be available by end of March, 2011. |
NeoProfen (ibuprofen lysine) Injection (9/8/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Lundbeck Inc. Customer service number: 1-888-514-5204 | Failure to meet a visible particulate quality specification. | Lundbeck voluntarily recalled NeoProfen as a safety precaution. As NeoProfen stock is being replenished by the manufacturer, supply is anticipated to be available in mid-2011. |
Neostigmine methylsulfate injection (4/14/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service: (1-888-229-0001) 0.5 mg/mL vials (NDC 10019-0271-10), Baxter 1 mg/mL, 10 mL vial (NDC 10019-0270-10) | Increased demand | Both strengths are on backorder with anticipation to have additional supply available in the March-April timeframe. |
| American Regent/Luitpold 631-924-4000 0.5 mg/mL 10 mL vials (NDC 00517-0034-25) and 1 mg/mL 10 mL vials (NDC 00517-0033-25) | Increased demand | Additional information regarding supplies of 0.5 mg/mL 10 mL vials (NDC 00517-0034-25), 1 mg/mL 10 mL vials (NDC 00517-0033-25) will be posted as soon as it's available. |
| APP 1-888-386-1300 0.5 mg/mL, 10 mL vial (NDC 63323-0382-10), 1 mg/mL 10 mL vials (NDC 63323-0383-10) | Increased demand | APP is currently allocating Neostigmine 1 mg/mL 10 mL vials due to increased demand. The 0.5 mg/mL 10 mL vials are on back order and the company estimates a release date early-May, 2011. |
Neupro (rotigotine transdermal system) (5/5/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| UCB, Inc 800-477-7877 | UCB has recalled all domestic lots | FDA has requested that UCB reformulate Neupro (rotigotine transdermal system) patches. UCB is committed to bringing Neupro to U.S. patients and has already made significant progress in the development of the new formulation. If you have additional questions about the status of Neupro, or about UCB’s Patient Access program for Neupro, please contact UCB Medical Information at 1-866-822-0068 (option 9). |
Nitroglycerin in Dextrose 5% (3/17/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service: (1-888-229-0001) 10 mg/100 mL, 250 mL (NDC 00338-1047-02) | Manufacturing delays | Baxter has premix nitroglycerin 10 mg/100 mL in dextrose 250 mL (NDC 00338-1047-02) and 20 mg/100 mL in dextrose 250 mL (NDC 00338-1049-02) available. The 40 mg/100 mL presentation is anticipated to be released by end of March, 2011. |
| Hospira Inc. 1-877-946-7747 10 mg/100 mL, 250 mL (NDC 00409-1483-02) | Manufacturing delays | Hospira has all premix nitroglycerin in dextrose presentations on back order with no estimated release date at this time. |
Norepinephrine Bitartrate Injection (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Customer Service: 1-800-562-4797 (Bedford 4 mL vial, package of 10 (NDC 55390-0002-10)) | Manufacturing delays | Bedford anticipates release in the next 3-months. |
| Hospira Inc. 1-877-946-7747 1 mg/mL 4 mL ampules (NDC 0409-1443-04) and 4 mL vials (NDC 0409-3375-04) | Increase in demand | Levophed (Norepinephrine Bitartrate Injection) 1 mg/mL 4 mL ampules (NDC 0409-1443-04) and 4 mL vials (NDC 0409-3375-04) are available for direct order for customers in dire need, and the company expects continuous deliveries going forward, with recovery estimated to occur in 3Q 2011.
|
| Teva Pharmaceuticals 1-800-545-8800 (Teva 4 mL vial, package of 10 (NDC 00703-1153-03)) | Teva temporarily discontinued norepinephrine in June 2010. | Teva anticipates having product available again 4th quarter 2011. |
| Sandoz Inc. | Sandoz, in conjunction with the FDA, is initiating a temporary importation of Norepinephrine Injection, to the United States market. Please see the Dear Healthcare Professional Letter (PDF - 296KB) for information about emergency supplies that are now available to help address the shortage. |
Oxsoralen (methoxsalen) 1% topical lotion (7/6/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Valeant Pharmaceuticals International 1-866-819-9007 | Manufacturing delays | There is not yet an estimated release date. |
Oxsoralen-Ultra (methoxsalen) 10 mg capsules (6/17/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Valeant Pharmaceuticals International Customer Service 1-800-556-1937 | Manufacturing delays | Valeant has released limited quantity of Oxsoralen-Ultra 10mg capsules to the market and is committed to ensuring the product is allocated properly to patients in need. Please see the Dear Healthcare Professional Letter (PDF - 49KB) for additional information. You may also contact Valeant by e-mail at This e-mail address is being protected from spambots. You need JavaScript enabled to view it for additional information. |
Phenylephrine HCl Injection (4/25/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Baxter Customer Service: 1-888-229-0001 10 mg/mL, 1 mL (25s - NDC 10019-163-12) | Increase in product demand | Baxter is currently experiencing a back order situation on the 1 mL vial (NDC 10019-163-12) Baxter has accelerated production and will have product available in mid May. Additional lots are scheduled for manufacturing and will be available for distribution in the June – July timeframe. |
| Sandoz Customer Service: 1-609-627-8500 10 mg/mL, 5 mL (25s - NDC 66758-0016-04); 10 mg/mL, 10 mL (1 - NDC 66758-0017-01) | Sandoz is currently on backorder as the current market requirements are more than current inventory due to the shortage in the market. | Sandoz anticipates increased product availability by the end of May. |
| American Regent Customer Service: 1-800-645-1706 10 mg/mL, 1 mL (25s - NDC 00517-0299-25) and 10 mg/mL, 5 mL (25s - NDC 00517-0405-25) | Manufacturing delays | American Regent cannot estimate a release date at this time. |
Potassium Phosphate (4/29/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. (1-877-946-7747) | Hospira, in agreement with FDA, will return to manufacturing Potassium Phosphate Injection to address the critical shortage so that patient needs continue to be met. Hospira understands the critical necessity of this molecule to the healthcare community and is quickly assessing manufacturing re-start timing and anticipated market recovery dates. At this time an ETA is unavailable. |
Procainamide HCL Injection, 100mg/ml (NDC# 00409-1902-01) 500mg/ml, (NDC# 00409-1903-01) (3/17/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. 1-877-946-7747 | Manufacturing delays | Hospira has available procainamide 500 mg/mL 2 mL vials (NDC 00409-1903-01) and anticipates the 100 mg/mL 10 mL vials to be released by late April. |
Propofol Injection 10mg/ml, 20ml 25s, 50ml 20s, 100ml 10s (updated 4/22/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Teva Pharmaceuticals 1-800-545-8800 | Teva Pharmaceuticals has discontinued their propofol injection. | Questions and Answers on the Propofol Shortage |
| Hospira Inc. 1-877-946-7747 | Hospira states their 2009 recall has been resolved and they are following FDA recommendations for good manufacturing practices. The company has their 20 mL and 50 mL presentations on intermittent back order due to increased demand and the 100 mL vials are on back order due to the prioritization of the 20mL and 50mL. We expect to be shipping the 100 mL vials to customers in May . All product is being shipped to sole contracted customers at this time. | |
| APP 1--888-386-1300 | APP has increased production in response to the increased demand. Please see additional information on availability in the Related Information section |
Renacidin Irrigation NDC# 00327-0011-05 (1/27/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Guardian Laboratories 1-800-645-5566 | Manufacturing delays | Guardian Laboratories has less than a one week supply as of 1/27/11 and continues to allocate product with no back-orders. The planned date of release will be posted once available. Guardian Labs cannot estimate when product will be available. |
Sodium Chloride 23.4% (3/17/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| APP 1-888-386-1300 30 mL vials (NDC 63323-0087-30), 100 mL vials (NDC 63323-0088-61), 200 mL vials (NDC 63323-0088-63) | Increased demand | APP has sodium chloride 23.4% solution for injection 30 mL and 100 mL vials on allocation. The 200 mL vials are on back order and the company estimates a release date of early-April, 2011. |
| American Regent, Inc. 1-800-645-1706 30 mL vials (NDC 00517-2930-25), 100 mL vials (NDC 00517-2900-25) | Increased demand | American Regent has sodium chloride 23.4% solution 30 mL vials on back order and expects release by end of March The 100 mL vials are on back order and the company cannot estimate a release date. |
| Hospira Inc. 1-877-946-7747 4 mEq/mL; 250 mL bottle (NDC 0409-1130-02) and 4 mEq/mL; 100 mL bottle (NDC 0409-1141-02) | Manufacturing delays | Hospira has sodium chloride 23.4% solution in 100 mL and 250 mL bulk glass containers on back order. |
Sodium Chloride 14.6% Injection (3/17/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. 1-877-946-7747 2.5 mEq/mL; 20 mL vial (NDC 0409-6657-73), 2.5 mEq/mL; 40 mL vial (NDC 0409-6660-75) | Increased demand | Hospira plans to release by end of March 2011. |
| APP 1-888-386-1300 14.6%, 20 mL vials (NDC 63323-0139-20), 40 mL vials (NDC 63323-0139-40) | Increased demand | APP does not yet have a release date. |
Sodium phosphate injection (updated 5/2/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira, Inc. 1-877-946-7747 3 mmol/mL, 15 mL vial (NDC 00409-7391-72) | Manufacturing delays | Hospira has sodium phosphate injections on back order and the company estimates a release date of 3Q, 2011. |
| American Regent/Luitpold 631-924-4000 5 mmol/mL, 5 mL vial (NDC 00517-3405-25), 5 mmol/mL, 15 mL vial (NDC 00517-3415-25), 5 mmol/mL, 50 mL vial (NDC 00517-3450-25) | Manufacturing delays | American Regent has sodium phosphate injections on back order and the company cannot estimate a release date. |
Succinylcholine injection (2/1/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Sandoz 1-800-525-8747 | Increased demand | Sandoz reports weekly releases are occurring for Anectine 20 mg/mL 10 mL vials (NDC 00781-3009-95) |
| Hospira 1-877-946-7747 | Manufacturing delays | Hospira is releasing Quelicin 20 mg/ml 10 mL Vials (NDC 0409-6629-02) and 100 mg/mL, 10 mL Vial (NDC 0409-6970-10) as they become available. |
Sulfamethoxazole 80mg/trimethoprim 16mg/ml injection (SMX/TMP) (8/5/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Teva Pharmaceuticals 1-800-545-8800 | Teva recalled Lot #31308526B/Exp. Date 9/2012 of SMX/TMP Injection 10 ml vials to the retail level because some vials may have defective crimps. | Teva manufactures 5 ml vials (NDC 00703-9503-03), 10 ml vials (NDC 00703-9514-03) and 30 ml vials (NDC 00703-9526-01). Limited emergency supplies are available from Teva. |
Tamiflu for Oral Suspension 12mg/ml 25 ml (NDC 00004-0810-95) (1/19/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Genentech: Product support and fulfillment: 1-800-551-2231 For medical information: 1-800-821-8590 | Increased demand | Genentech has Tamiflu for Oral Suspension on backorder, however supplies remain in distribution at wholesalers and pharmacies. Tamiflu 75mg, 45 mg and 30 mg capsules remain available. For those patients who have difficulty swallowing capsules, the contents can be mixed into sweetened liquids, such as chocolate syrup, as directed by a healthcare professional. If there is difficulty locating commercial Tamiflu for Oral Suspension, FDA would like to remind healthcare professionals of the FDA-approved Instructions for the emergency compounding of an oral suspension from Tamiflu 75 mg capsules. These instructions provide for an alternative oral suspension when commercially manufactured oral suspension formulation is not readily available. Please refer to the Tamiflu package insert for information regarding compounding an oral suspension from Tamiflu 75mg capsules or see the following link for healthcare professionals: Tamiflu |
Thiotepa for Injection, Bedford 15 mg/mL vial (NDC 55390-0030-10) (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Laboratories Customer Service 1-800-562-4797 | Manufacturing delays | Bedford anticipates release mid-May. |
Thyroid (desiccated) tablets (2/12/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Forest RLC | Forest reports manufacturing issues involving the raw material and RLC reports increased demand. FDA has not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market. | FDA approved levothyroxine products continue to be available from multiple manufacturers. |
Thyrolar Tablets (12/31/2009)
| Company/Products | Reason | Related Information |
|---|---|---|
| Forest Pharmaceuticals | Manufacturing delays | Forest has not yet reported when Thyrolar will be available. |
Tromethamine 500 mL Injection, NDC 0409-1593-04 (10/22/2010)
| Company/Products | Reason | Related Information |
|---|---|---|
| Hospira Inc. 1-877-946-7747 | Manufacturing delays | Hospira anticipates next product release 1Q 2011. |
Vecuronium Injection (updated 5/10/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Bedford Laboratories Customer Service 1-800-562-4797 | Increase in demand | Bedford anticipates release of the 10mg product in early May and the 20mg product in the next 3-months. |
| Sun Pharmaceutical Industries, Inc. 1-800-818-4555 | Increase in demand | Sun Pharmaceutical Industries (Distributor: Caraco Pharmaceutical Labs, Ltd.) is continuing to release product as it becomes available. Vecuronium Bromide for Injection 10 mg 10 vials NDC 41616-0931-44 Vecuronium Bromide for Injection 20 mg 10 vials NDC 41616-0932-44 |
| Teva Pharmaceuticals 1-800-545-8800 | On manufacturing hold | Teva has the 10mg/vial (NDC 00703-2914-03) and 20 mg/vial (NDC 00703-2925-03) on backorder. |
| Hospira, Inc. 1-877-946-7747 | Manufacturing Delays | Hospira will be off-market for an undefined period. |
Xeloda 500 Tablets (3/25/2011)
| Company/Products | Reason | Related Information |
|---|---|---|
| Genentech 1-800-GENENTECH | Recall of 13 manufacturing lots of the customary 120 count bottles currently approved for use in the US. Genentech is working closely with FDA to ensure that US supply of Xeloda 500mg tablets remains unchanged. | Please see the Dear Healthcare Professional Letter (PDF - 95KB). |
-
Read more http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm#bicnu